Device Classification Name |
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
|
510(k) Number |
K983900 |
Device Name |
VENOMETER |
Applicant |
ADVANCED MEDICAL TECHNOLOGY LTD. |
9712 S. ALTAMONT DR. |
SANDY,
UT
|
|
Applicant Contact |
WILLIAM E MCKAY |
Correspondent |
ADVANCED MEDICAL TECHNOLOGY LTD. |
9712 S. ALTAMONT DR. |
SANDY,
UT
|
|
Correspondent Contact |
WILLIAM E MCKAY |
Regulation Number | 870.2780 |
Classification Product Code |
|
Date Received | 11/03/1998 |
Decision Date | 01/29/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|